Renal Division

Medicine, Germany

Renal Division

Medicine, Germany
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News Article | May 4, 2017
Site: globenewswire.com

PHOENIX, Ariz., May 04, 2017 (GLOBE NEWSWIRE) -- Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") announced that Rohit Vishnoi, a seasoned healthcare executive, has been appointed to the Company’s Board of Directors, effective as of May 2, 2017.  Mr. Vishnoi has also been appointed to the Company’s Science and Research and Development Committee and Nominating and Corporate Governance Committee. “Rohit Vishnoi’s many assets include a proven track record of balancing strategy with the clinical and technical requirements necessary to successfully deliver pharmaceutical and medical devices products to market,” said Steven Meyer, Chairman of the Board, Insys Therapeutics, Inc. “Mr. Vishnoi, along with the Company’s President and Chief Executive Officer Saeed Motahari, who also was recently appointed, enhance the mix of our Board, bringing to bear their considerable experience and insight.” Mr. Vishnoi, who has served on numerous boards, is currently a Member of the Board of Directors and a Member of the Compensation Committee at Outset Medical, a medical technology company, and a member of the Advisory Board for the Biomedical Engineering Department at Northwestern University. He worked at Hospira, a Pfizer Company, from 2009-2016, where he held increasingly responsible positions at the global device organization, culminating in Vice President, R&D. He also was a Member of the Board of Directors of the Hospira Foundation, the organization’s philanthropic outreach effort, from 2012 until its closing in 2015. At the Baxter Healthcare Corporation, where he worked from 1988-2009, he helped reinvigorate its Renal Division, among other accomplishments. A recipient of numerous awards, including Janus de la Sante and the Medical Design Excellence Award, Mr. Vishnoi graduated from the Indian Institute of Technology in Kanpur, India, with a BTech. He has a MS in Biomedical Engineering and in Electrical Engineering from the Rensselaer Polytechnic Institute in Troy, NY, where he also received a PhD in Electrical Engineering. In 1995, Mr. Vishnoi received a MBA, Marketing and Finance, from the Kellogg School of Management at Northwestern University. He holds 11 patents for medical products. About Insys Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. Insys currently markets one product, SUBSYS® (fentanyl sublingual spray) but has received approval for the marketing of SYNDROS™ (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule.  Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need. SUBSYS® and SYNDROS™ are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc. Forward-Looking Statements This press release contains forward-looking statements including regarding the belief that SYNDROS has distinct advantages over the current formulation of dronabinol in soft gel capsule. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. For a description of these risks facing the company, please see the risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2016 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements, except as may be required by law.


News Article | April 20, 2017
Site: www.eurekalert.org

When the kidneys - vital organs for filtering the body's entire blood supply - become injured, it can set in motion an unfortunate chain of events that leads to a decline in health. Sometimes, in response to chronic injury, the body begins an aberrant repair process known as fibrosis, in which normal fibroblast cells transform into myofibroblasts, proliferate out of control, migrate and form scar tissue. Once scar tissue begins to form, functional cells begin to die, and the scar tissue multiplies. Investigators have been looking for a way to break this cycle, and new findings indicate that a gene known as SMOC2 may point the way to a new intervention that could prevent this cascade of events. Previous studies by investigators at Brigham and Women's Hospital had identified SMOC2 as a protein that was highly upregulated in the kidneys of mice with fibrosis. In a new study published in JCI Insights, investigators report that increasing SMOC2 in the kidney helped initiate and continue the progression of kidney fibrosis, while tamping down SMOC2 prevented it. To test this, researchers overexpressed SMOC2 in a mouse model of kidney fibrosis and performed RNA sequencing to investigate the mechanisms responsible for fibrotic development. They found that SMOC2 activated a fibroblast-to-myofibroblast transition (FMT). The team then used two approaches to "silence" SMOC2 - a genetic approach, by using SMOC2 knockout mice, and a pharmacologic approach, by administering SMOC2 siRNA. Using these approaches, researchers were successful in tamping down the protein's production, which protected against fibrosis development. Corresponding author Vishal Vaidya, PhD, of BWH's Renal Division, notes that one of the exciting things about SMOC2 is that it can be detected in a patient's urine. Now that a functional connection between the protein and kidney fibrosis is becoming clearer, SMOC2 is looking like an increasingly useful biomarker for detecting fibrosis. In addition, SMOC2 may be a promising therapeutic target for an unmet medical need. "We want to be able to intervene before the tissue becomes severely fibrotic to the point of no return. Our investigation indicates that SMOC2 could be a key to protecting against kidney fibrosis initiation and progression," said Vaidya. This work was made possible through funding by the Partners Innovation Discovery Grant, Outstanding New Environmental Sciences, Innovation in Regulatory Science Award from Burroughs Wellcome Fund, the Harvard Catalyst, the National Institutes of the Health, the National Institute of Environmental Health Sciences, the Harvard Medical School Laboratory of Excellence in Systems Pharmacology and the Giovanni Armenise-Harvard Foundation.


News Article | May 19, 2017
Site: www.rdmag.com

More than 45 million couples worldwide grapple with infertility, but current standard methods for diagnosing male infertility can be expensive, labor-intensive, and require testing in a clinical setting. Cultural and social stigma, and lack of access in resource-limited countries, may prevent men from seeking an evaluation. Investigators at Harvard-affiliated Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) set out to develop a home-based diagnostic test that could be used to measure semen quality with a smartphone-based device. New findings by the team indicating that the analyzer can identify abnormal semen samples based on sperm concentration and motility criteria with approximately 98 percent accuracy are published online in today’s Science Translational Medicine. “We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests,” said Hadi Shafiee, a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at BWH. “Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism, and disappointment. Current clinical tests are lab-based, time-consuming, and subjective. This test is low-cost, quantitative, highly accurate, and can analyze a video of an undiluted, unwashed semen sample in less than five seconds.” The analyzer consists of an optical attachment that can connect to a smartphone and a disposable device onto which a semen sample can be loaded. The new test utilizes the advancements in consumer electronics and microfabrication. A disposable microchip with a capillary tip and a rubber bulb is used for simple, power-free semen sample handling. The team also designed a user-friendly smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count. To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. Overall, the smartphone-based device was able to detect abnormal semen samples based on WHO thresholds for sperm concentration and motility (sperm concentration less than 15 million sperm/ml and/or sperm motility less than 40 percent) with an accuracy of 98 percent. The team also evaluated how well both trained and untrained users performed the test using the smartphone-based device. “The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game-changer,” said John Petrozza, a co-author of the study and director of the MGH Fertility Center. “More than 40 percent of infertile couples have difficulty conceiving due to sperm abnormalities and this development will provide faster and improved access to fertility care. By working with Dr. Shafiee and his lab at BWH, and utilizing our clinical fertility expertise here at MGH, we have really been able to create a product that will benefit a lot of people.” Shafiee’s team, which focuses on developing new technologies using microfluidics, sees many applications for the technology. In addition to at-home male fertility testing for couples trying to conceive, the device could also be used by men who have had a vasectomy. Usually, men must go for office visits with a urologist for several months after the surgery to ensure that the operation was successful; the new test may allow them to be monitored at home. The test could also be used by animal breeders to confirm the quality of a sample. Beyond semen analysis, the device is also compatible with testing blood and saliva samples. “My job is to try to understand some of the problems patients and physicians face in the clinic and to help develop new solutions. We are always thinking about what’s next and how to develop something new,” said Shafiee, who is an assistant professor of medicine at Harvard Medical School. The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval.


News Article | May 19, 2017
Site: www.rdmag.com

More than 45 million couples worldwide grapple with infertility, but current standard methods for diagnosing male infertility can be expensive, labor-intensive, and require testing in a clinical setting. Cultural and social stigma, and lack of access in resource-limited countries, may prevent men from seeking an evaluation. Investigators at Harvard-affiliated Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) set out to develop a home-based diagnostic test that could be used to measure semen quality with a smartphone-based device. New findings by the team indicating that the analyzer can identify abnormal semen samples based on sperm concentration and motility criteria with approximately 98 percent accuracy are published online in today’s Science Translational Medicine. “We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests,” said Hadi Shafiee, a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at BWH. “Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism, and disappointment. Current clinical tests are lab-based, time-consuming, and subjective. This test is low-cost, quantitative, highly accurate, and can analyze a video of an undiluted, unwashed semen sample in less than five seconds.” The analyzer consists of an optical attachment that can connect to a smartphone and a disposable device onto which a semen sample can be loaded. The new test utilizes the advancements in consumer electronics and microfabrication. A disposable microchip with a capillary tip and a rubber bulb is used for simple, power-free semen sample handling. The team also designed a user-friendly smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count. To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. Overall, the smartphone-based device was able to detect abnormal semen samples based on WHO thresholds for sperm concentration and motility (sperm concentration less than 15 million sperm/ml and/or sperm motility less than 40 percent) with an accuracy of 98 percent. The team also evaluated how well both trained and untrained users performed the test using the smartphone-based device. “The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game-changer,” said John Petrozza, a co-author of the study and director of the MGH Fertility Center. “More than 40 percent of infertile couples have difficulty conceiving due to sperm abnormalities and this development will provide faster and improved access to fertility care. By working with Dr. Shafiee and his lab at BWH, and utilizing our clinical fertility expertise here at MGH, we have really been able to create a product that will benefit a lot of people.” Shafiee’s team, which focuses on developing new technologies using microfluidics, sees many applications for the technology. In addition to at-home male fertility testing for couples trying to conceive, the device could also be used by men who have had a vasectomy. Usually, men must go for office visits with a urologist for several months after the surgery to ensure that the operation was successful; the new test may allow them to be monitored at home. The test could also be used by animal breeders to confirm the quality of a sample. Beyond semen analysis, the device is also compatible with testing blood and saliva samples. “My job is to try to understand some of the problems patients and physicians face in the clinic and to help develop new solutions. We are always thinking about what’s next and how to develop something new,” said Shafiee, who is an assistant professor of medicine at Harvard Medical School. The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval.


Goldberg S.,Renal Division | Senior R.M.,University of Washington | Miner J.H.,Renal Division | Miner J.H.,University of Washington
Journal of the American Society of Nephrology | Year: 2010

Mutation of the mouse laminin 5 gene results in a variety of developmental defects, including defects in kidney structure and function. Whereas the total absence of laminin α5 results in breakdown of the glomerular basement membrane (GBM) and failed glomerular vascularization, a hypomorphic Lama5 mutation (the Lama5neo allele) results in proteinuria, hematuria, polycystic kidney disease (PKD), and death 3 to 4 weeks after birth. Here, we examined the role of podocyte-derived laminin α5 via podocyte-specific inactivation of Lama5 and podocyte-specific rescue of the Lama5neo mutation. Podocyte-specific inactivation of Lama5 resulted in varying degrees of proteinuria and rates of progression to nephrotic syndrome. The GBM of proteinuric mice appeared thickened and "moth-eaten," and podocyte foot processes became effaced. Podocyte-specific restoration of laminin α5 production using two distinct strategies in Lama5neo/neo mice resulted in the resolution of proteinuria, hematuria, and PKD. These results suggest that the development of normal GBM structure and function requires podocytederived laminin α5 during and after glomerulogenesis and present a unique mechanism for the pathogenesis of PKD in these mice. Copyright © 2010 by the American Society of Nephrology.


Lam A.Q.,Renal Division | Lam A.Q.,Harvard Stem Cell Institute | Freedman B.S.,Renal Division | Freedman B.S.,Harvard Stem Cell Institute | And 8 more authors.
Journal of the American Society of Nephrology | Year: 2014

Human pluripotent stem cells (hPSCs) can generate a diversity of cell types, but few methods have been developed to derive cells of the kidney lineage. Here, we report a highly efficient system for differentiating human embryonic stem cells and induced pluripotent stem cells (referred to collectively as hPSCs) into cells expressing markers of the intermediate mesoderm (IM) that subsequently form tubule-like structures. Treatment of hPSCs with the glycogen synthase kinase-3β inhibitor CHIR99021 induced BRACHYURY+MIXL1+ mesendoderm differentiation with nearly 100% efficiency. In the absence of additional exogenous factors, CHIR99021-induced mesendodermal cells preferentially differentiated into cells expressing markers of lateral plate mesoderm with minimal IM differentiation. However, the sequential treatment of hPSCs with CHIR99021 followed by fibroblast growth factor-2 and retinoic acid generated PAX2+LHX1+ cells with 70%-80% efficiency after 3 days of differentiation. Upon growth factor withdrawal, these PAX2+LHX1+ cells gave rise to apically ciliated tubular structures that coexpressed the proximal tubule markers Lotus tetragonolobus lectin, N-cadherin, and kidney-specific protein and partially integrated into embryonic kidney explant cultures. With the addition of FGF9 and activin, PAX2+LHX1+ cells specifically differentiated into cells expressing SIX2, SALL1, and WT1, markers of cap mesenchyme nephron progenitor cells. Our findings demonstrate the effective role of fibroblast growth factor signaling in inducing IM differentiation in hPSCs and establish the most rapid and efficient system whereby hPSCs can be differentiated into cells with features characteristic of kidney lineage cells. Copyright © 2014 by the American Society of Nephrology.


Cravedi P.,Renal Division | Heeger P.S.,Renal Division | Heeger P.S.,Recanati Miller Transplant Institute | Heeger P.S.,Mount Sinai School of Medicine
Current Opinion in Organ Transplantation | Year: 2012

Purpose of review: Tailoring immunosuppressive drugs to an individual's needs is crucial to improve long-term outcomes of organ transplant patients. The purpose of this review is to summarize the data on promising biomarkers able to detect the risk of acute or chronic rejection and to discuss the potential issues for their implementation in the clinic. Recent findings: Multiple publications have indicated that circulating antibodies targeting human leukocyte antigen (HLA) and non-HLA antigens as well as donor-specific memory T cells are associated with accelerated graft failure. Other studies published within the year show that specific genomic and proteomic signatures obtained from urine, blood, and graft tissue correlate with acute rejection in kidney and heart transplant patients. Summary: The development of reliable biomarkers is crucial for individualizing therapy aimed at extending allograft survival and improving patient health. Emerging data indicate that monitoring assays, likely used in panels, have the potential to be diagnostic and possibly predictive of long-term outcome. In addition to ongoing discovery efforts, progress in the field will require multicenter validation, assay standardization, and commercialization so as to efficiently deliver reliable testing strategies to the practicing clinician. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Charytan D.M.,Renal Division | Yang S.S.,Renal Division | McGurk S.,Brigham and Women's Hospital | Rawn J.,Brigham and Women's Hospital
Nephrology Dialysis Transplantation | Year: 2010

Background. Improved understanding of the incidence and risk factors for operative complications and long-term mortality following coronary artery bypass grafting (CABG) is needed to better define the optimal role for CABG in patients with chronic kidney disease (CKD).Methods. We analysed 2438 patients who underwent CABG at a single centre between 2005 and 2008. Multivariable regression was used to analyse associations and to generate a CKD-specific predictive tool. Results. Operative mortality was 4.8% in individuals with stage 3 CKD, 7.1% in individuals with stage 4-5 CKD and 2.2% in those without significant CKD (P<0.001). CKD was associated with post-operative blood transfusion, acute kidney injury, myocardial injury and cardiac arrest, and use of exogenous blood and acute kidney injury were strongly associated with in-hospital death in CKD patients. Patients with stage 3 (HR 1.64, 95% CI 1.30-45.94) and stage 4-5 CKD (HR 2.77, 95% CI 1.00-2.68) were more likely to die during follow-up than those without CKD, but mortality rates were low among patients who survived to discharge-stage 3 (0.006 deaths/year) and stage 4-5 CKD (0.009/year). A scoring system including urgent or emergent surgery (OR 2.30), prior cardiac surgery (OR 3.06), concurrent valve surgery (OR 2.06), preoperative shock (OR 6.18), and prior stroke (OR 1.98) had 96.4% percent specificity for the detection of in-hospital death in patients with CKD. Conclusions. Perioperative mortality and morbidity remain more frequent in patients with stage 3-5 CKD than patients with preserved renal function, but long-term outcomes in patients surviving hospitalization are favourable. We have developed a predictive tool that holds promise as a means of identifying CKD patients most likely to survive surgery and benefit from CABG. © The Author 2010.


Braun A.B.,Renal Division | Gibbons F.K.,Massachusetts General Hospital | Litonjua A.A.,Pulmonary and Critical Care Division | Giovannucci E.,Harvard University | And 2 more authors.
Critical Care Medicine | Year: 2012

Objective: We hypothesized that deficiency in 25-hydroxyvitamin D at critical care initiation would be associated with all-cause mortalities. Design: Two-center observational study. Setting: Two teaching hospitals in Boston, MA. Patients: The study included 1,325 Patients, age ≥ 18 yrs, in whom 25-hydroxyvitamin D was measured 7 days before or after critical care initiation between 1998 and 2009. Measurements: 25-hydroxyvitamin D was categorized as deficiency in 25-hydroxyvitamin D (≤15 ng/mL), insufficiency (16-29 ng/mL), and sufficiency (≥ 30 ng/mL). Logistic regression examined death by days 30, 90, and 365 postcritical care initiation and in-hospital mortality. Adjusted odds ratios were estimated by multivariable logistic regression models. Interventions: None. KEY Results: 25-hydroxyvitamin D deficiency is predictive for short-term and long-term mortality. Thirty days following critical care initiation, Patients with 25-hydroxyvitamin D deficiency have an odds ratio for mortality of 1.85 (95% confidence interval 1.15-2.98; p = .01) relative to Patients with 25-hydroxyvitamin D sufficiency. 25-hydroxyvitamin D deficiency reMains a significant predictor of mortality at 30 days following critical care initiation following multivariable adjustment for age, gender, race, Deyo-Charlson index, sepsis, season, and surgical vs. medical patient type (adjusted odds ratio 1.94; 95% confidence interval 1.18-3.20; p = .01). Results were similarly significant at 90 and 365 days following critical care initiation and for in-hospital mortality. The association between vitamin D and mortality was not modified by sepsis, race, or neighborhood poverty rate, a proxy for socioeconomic status. Conclusion: Deficiency of 25-hydroxyvitamin D at the time of critical care initiation is a significant predictor of all-cause patient mortality in a critically ill patient population. © 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.


Hung C.,University of Washington | Linn G.,University of Washington | Chow Y.-H.,University of Washington | Kobayashi A.,Renal Division | And 6 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2013

Rationale: The origin of cells that make pathologic fibrillar collagen matrix in lung disease hasbeen controversial. Recent studies suggest mesenchymal cells may contribute directly to fibrosis. Objectives:Tocharacterize discrete populations ofmesenchymal cells in the normal mouse lung and to map their fate after bleomycininduced lung injury. Methods: We mapped the fate of Foxd1-expressing embryonic progenitors and their progeny during lung development, adult homeostasis, and after fibrosing injury in Foxd1-Cre; Rs26-tdTomato-R mice. We studied collagen-I(a)1producing cells in normal and diseased lungs using Coll-GFPTg mice. Measurements and Main Results: Foxd1-expressing embryonic progenitors enter lung buds before 13.5 days post-conception, expand, and formanextensive lineageofmesenchymal cellsthathavecharacteristics of pericytes. A collagen-I(a)1expressing mesenchymal population of distinct lineage is also found in adult lung, with features of a resident fibroblast. Incontrast to resident fibroblasts, Foxd1progenitorderived pericytesare enriched in transcripts for innateimmunity, vasculardevelopment, WNTsignalingpathway, and cell migration. Foxd1progenitor derived pericytes expand after bleomycin lung injury, and activate expression of collagen-I(a)1 and the myofibroblast marker aSMA in fibrotic foci. In addition, our studies suggest a distinct lineage of collagen-I(a)1expressing resident fibroblasts that also expands after lung injury is a second major source of myofibroblasts. Conclusions:We conclude that the lung contains an extensive population of Foxd1 progenitorderived pericytes that are an important lung myofibroblast precursor population. Copyright © 2013 by the American Thoracic Society.

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